ViroSeq HIV-1 Genotyping System

Intended Use

The ViroSeq HIV-I Genotyping System is intended for use in detecting HIV genomic mutations that confer resistance to specific types of antiretroviral drugs, as an aid in monitoring and treating HIV infection. Specifically, the ViroSeq HIV-I Genotyping System can be used to:

• Detect HIV-I Subtype B viral resistance in plasma samples collected in EDTA with a viral load ranging from 2,000 to 750,000 copies/mL
• Genotype the entire HIV-1 protease gene from codons 1to99 and two-thirds of the reverse transcriptase (RT) gene from codons I to 335

In order to use the ViroSeq HIV-1 Genotyping System:

• The user (operator or technologist) must be trained in its use.
• Interpretation and application of the results should be done by a qualified physician.

The kit is not to be used as a screening test for HIV or as a diagnostic test to confirm the presence of HIV infection.

The kit is not to be used as a screening test for HIV or as a diagnostic test to confirm the presence of HIV infection.

Limitations of the Procedure

Reagents and Chemistry

• Only trained users are allowed to perform the ViroSeq HIV-I Genotyping System.
• Accurate and reliable results are dependent on proper sample collection and storage prior to testing.
• Blood collected using Heparin tubes is unsuitable for use with PCR and this assay.
• Testing for antiretroviral drug resistance has only been validated on patient samples with viral loads between 2,000 and 750,000 copies per mL. In a typical HIV positive patient population in the U.S. that is on HIV highly active antiretroviral therapy (HAART), about 25% of the patients can be expected to have suppressed viral loads. These samples may not always generate interpretable results with the ViroSeq HIV-I Genotyping System if the viral load is below I,000 copies/mL. Users should test samples with a viral load of2,000 copies/mL or greater.
• Regardless of viral load, the agarose band intensity of the RT-PCR product must be equal to or greater than the intensity of the 20-ng mass ladder band to produce a high-quality sequence.
• The presence of AmpErase UNG in the ViroSeq HIV-I Genotyping System reduces the risk of contamination with previously amplified product only. Sample to sample contamination, or contamination from the positive control, can still occur. Careful adherence to work area setup and the protocol reduces the possibility of contamination.
• Only Applied Biosystems thermal cyclers and automated DNA sequencers can be used with this assay.
• In accordance with the FDA Guidance document for HIV-I genotyping, analytical studies using the ViroSeq HIV-I Genotyping System have not been completed at the limit of detection for the following mutations:

Warnings and Precautions

• For In Vitro Diagnostic Use Only.
• This test is for use with human plasma collected with EDTA anticoagulant only. Do not use plasma collected in heparin with this procedure as it has been shown to inhibit PCR.
• Do not pipette by mouth.
• Do not eat, drink, or smoke in laboratory work areas. Wear appropriate personal protective equipment when handling specimens and kit reagents (e.g., safety glasses, gloves, and protective clothing). Wash hands thoroughly after handling specimens and kit reagents.
• Avoid microbial and ribonuclease contamination ofreagents when removing aliquots from reagent bottles. We recommend the use of sterile disposable pipettes and pipette tips.
• Do not pool reagents from different lots or from different tubes of the same lot.
• Do not use this kit after its expiration date.
• Read and understand the Safety Data Sheets (SDSs) for the ViroSeq System and other chemicals before storing, handling, or working with any chemical or hazardous material. Safety Data Sheets (SDSs) are available by calling Abbott Molecular at 1-800-553-7042. For chemicals not manufactured or distributed by Abbott Molecular, contact the chemical manufacturer for SDSs and guidance on storage, safe handling, and disposal.
• Due to the presence of guanidine thiocyanate in the Viral Lysis Buffer, do not add acids or bleach to the reagent or to the liquid waste. Toxic gases may be generated.
• Minimize contact with chemicals. Wear appropriate personal protective equipment when handling chemicals (e.g., safety glasses, gloves, and protective clothing). For additional handling guidelines, consult the SOS.
• Minimize inhalation of chemicals. Do not leave chemical containers open. Use only with adequate ventilation. For additional safety guidelines, consult the SDS.
• Check regularly for chemical leaks or spills. If a leak or spill occurs, follow the manufacturer's cleanup procedures as recommended on the SDS.
• Comply with all local, state/provincial, or national laws and regulations related to chemical storage, handling, and disposal.
• Minimize contact with and inhalation of chemical waste. Wear appropriate personal protective equipment when handling chemical wastes (e.g., safety glasses, gloves, or protective clothing). Handle chemical wastes in a fume hood.
• Dispose of unused reagents and waste in accordance with good laboratory practices and local, state/provincial, or national environmental and health regulations.
• LASER HAZARD. Exposure to direct or reflected laser light at 40 mW for 0.1 seconds can bum the retina and leave permanent blind spots. Never look directly into the laser beam or allow a reflection of the beam to enter your eyes. Follow the manufacturer's recommendations for appropriate protective eye-wear and clothing.

Rx Only

To learn more about ViroSeq HIV-1 Genotyping System please visit: https://www.molecular.abbott/us/en/products/infectious-disease/viroseq-hiv-1-genotyping-system